Brian Caselli
- Role
- Sumitomo Pharma America, Inc.
- Location
- Bethany, CT, US
- LinkedIn followers
- 500 followers
About Brian Caselli
Brian Caselli is a seasoned regulatory affairs professional with almost 25 years of…
Experience
Skills
- Regulatory Submissions
- Drug Development
- U.s. Title 21 Cfr Part 11 Regulation
- Gcp
- Biotechnology
- Medical Writing
- Regulatory Affairs
- Lifesciences
- Pharmaceuticals
- Regulatory Requirements
- Ind
- Pharmaceutical Industry
- Sop
- Fda
- Glp
- Validation
- Ectd
- 21 Cfr Part 11
- Document Management
- U.s. Food and Drug Administration (Fda)
- Documentum
- Good Laboratory Practice (Glp)
- Infectious Diseases
- Clinical Study Design
- Electronic Common Technical Document (Ectd)
- Clinical Data Management
- Clinical Trials
- Standard Operating Procedure (Sop)
- Oncology
- Protocol
- Clinical Development
- Change Control
- Gmp
- Continuous Improvement
- Life Sciences
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